Parasitic eye infections tied to contact lens solution
An inspection conducted by the US Food and Drug Administration determined that a subsidiary of Abbott Park, Ill.-based Abbott Laboratories Inc. failed to disclose multiple reports of a serious parasitic eye infection for more than a year.
An inspection conducted by the US Food and Drug Administration determined that a subsidiary of Abbott Park, Ill.-based Abbott Laboratories Inc. failed to disclose multiple reports of a serious parasitic eye infection for more than a year.
Law firm Schmidt & Clark's managing partner, Michael Schmidt, says the documents reveal the link between Acanthamoeba Keratitis and a popular contact lens solution sold by AMO.
"It confirms our suspicion that AMO knew, or should have known, that there was a significant increase in Acanthamoeba Keratitis cases associated with Complete MoisturePlus," Mr Schmidt says in the article.
The report, obtained under the Freedom of Information Act, revealed that FDA inspectors discovered that AMO failed to disclose at least nine reported cases of the sight-threatening eye infection Acanthamoeba Keratitis among users of the company's Complete MoisturePlus contact lens solution.
According to the report, AMO began receiving complaints of serious corneal infections in February 2006, but those reports were not disclosed until an FDA inspection in late May and early June 2007. The Centres for Disease Control launched its own investigation after receiving increasing reports of the rare infection.
AMO finally recalled Complete MoisturePlus in May 2007 after the release of data showed that users of the product were seven times more likely to be infected with Acanthamoeba Keratitis than those who never used Complete MoisturePlus. The FDA subsequently categorized the withdrawal as a Class I recall, a status reserved for situations where there is a reasonable probability that the recalled product will cause serious health problems or deaths.
